{"abstract":"The Food and Drug Administration (FDA or Agency or we) is issuing this final rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. This final rule is in response to our enhanced understanding in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/06/22/2016-14721.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1271,"title":21}],"citation":"81 FR 40512","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective August 22, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-1484"],"dockets":[],"document_number":"2016-14721","effective_on":"2016-08-22","end_page":40518,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/06/22/2016-14721.xml","html_url":"https://www.federalregister.gov/documents/2016/06/22/2016-14721/revisions-to-exceptions-applicable-to-certain-human-cells-tissues-and-cellular-and-tissue-based","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-14721?publication_date=2016-06-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-06-22/2016-14721/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":2241,"last_updated":"2026-08-24 00:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-06-22/pdf/2016-14721.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-14721.pdf?1466513275","publication_date":"2016-06-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/06/22/2016-14721.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-N-1484","supporting_documents_count":0,"docket_id":"FDA-2014-N-1484","regulation_id_number":null,"title":"Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products","checked_regulationsdotgov_at":"2016-07-12T06:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":40512,"subtype":null,"title":"Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products","toc_doc":"Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products","toc_subject":null,"topics":["Biologics","Drugs","Human cells and tissue-based products","Medical devices","Reporting and recordkeeping requirements"],"type":"Rule","volume":81}